CN104971389A - A Device And A Method To Controllably Assist Movement Of A Mitral Valve - Google Patents

Abstract

A device, a kit and a method is presented for permanently augmenting the pump function of the left heart. The mitral valve plane is assisted in a movement along the left ventricular long axis during each heart cycle. The very close relationship between the coronary sinus and the mitral valve is used by various embodiments of a medical device providing this assisted movement. By means of catheter technique an implant is inserted into the coronary sinus, the device is augmenting the up and down movement of the mitral valve and thereby increasing the left ventricular diastolic filling when moving upwards and the piston effect of the closed mitral valve when moving downwards.

Description

Device and method for controllably assisting mitral valve movement

related application

This application claims priority to U.S. Provisional Application Serial No. 61/317,619, filed March 25, 2010, and Swedish Application Serial No. SE1050282-1, filed March 25, 2010, both entitled "Device , a Kit and a Method for Heart Support", the contents of which are incorporated herein by reference.

technical field

The present invention relates to an intravascular blood circulation enhancement device, a system for intravascular blood circulation enhancement, and a method for enhancing left ventricular pumping function in a patient. The present invention is especially useful for enhancing the pumping function of the left ventricle as a permanent measure for the treatment of heart failure diseases of cardiac insufficiency.

Background technique

If the heart function is chronically insufficient, continuous support to the heart function may be required. In general, heart failure (HF), more commonly known as congestive heart failure (CHF), is a disease in which the heart cannot support the metabolic demands of body tissues and cannot maintain adequate blood pressure and cardiac output. The term "congestive" refers to the pooling of blood and fluid in front of the pumping ventricle due to insufficient forward pumping; in most cases it is caused by disease of the left ventricular muscle. It is a characteristic of heart cells that they cannot regenerate after damage or cell death, so heart disease has a tendency to worsen rather than heal when heart cells are damaged. Heart cells die for many reasons, the most common being ischemic heart disease, a condition in which arteries supplying blood to the heart muscle become blocked, leading to myocardial infarction (MI). Viruses damage muscle cells, and some diseases, such as cardiomyopathy, have unknown causes. Long-standing end-stage hypertension can also lead to end-stage heart failure. The use of cardiotonic drugs (such as digoxin) or diuretics can help relieve the condition for a period of time, but only treat the symptoms. Congestive heart failure is a progressive, incurable, disabling and ultimately fatal disease. According to the American Heart Association's homepage, there are currently more than 5 million patients with congestive heart failure in the United States and 550,000 more cases are added each year. There are 40,000 patients in the United States who are at risk of surviving only with a heart transplant. However, only 2,500 transplants are performed each year in the United States due to the limited number of suitable organs. The numbers for the remaining industrialized countries can be extrapolated.

Total artificial hearts were introduced in the 1960's by DeBakey, in the 1980's by Jarvik and others, and more recently by Copeland (CardioWest, Total Artificial Heart), in which the entire natural heart is removed and replaced with a mechanical device. However, these devices are still based on complex designs and are very invasive to install in the patient. Operational failure of the device is fatal.

Other technologies exist that support only the failing left ventricle, called left ventricular assist devices (LVADs). The most common left ventricular assist devices are the Novacor and HeartMate devices. Typically, this device requires major open-heart surgery that uses extracorporeal circulation with the help of a heart-lung machine while stopping (or removing) the heart. The devices are bulky, with the Novacor weighing 1,800 grams and the HeartMate at 1,200 grams. There are currently smaller axial flow pumps such as the HeartMate II, Jarvik 2000, and MicroMed DeBakey VAD. In addition, major open-heart surgery is still required when these devices are installed and connected in the left ventricular cavity and aorta by great vessel grafting. Due to high frequency of complications, high mortality, and limited durability, the device is used almost exclusively as a bridge to heart transplantation. Their use is limited due to the high price of the device (up to $150,000).

None of the described devices for permanent implantation are suitable for minimally invasive catheter-based insertion, instead they all involve major open heart surgery. Clearly there is a need for simpler devices, and the scope of the present invention is to omit major open heart surgery and enable implantation to be performed using catheter techniques.

Moreover, healthcare professionals are constantly looking for improved devices and methods.

Accordingly, there is a need for improved systems and/or methods that continuously enhance or assist the pumping function of the left ventricle of a patient's heart. Advantageously, the system does not affect the cardiac cycle of the heart.

Accordingly, improved systems and/or methods that continuously enhance or assist the pumping function of the heart's left ventricle in a patient would be advantageous, particularly systems and methods that improve adaptability, cost-effectiveness, long-term function, and/or patient friendliness. /or methods would be beneficial.

Contents of the invention

Accordingly, embodiments of the present invention preferably provide medical devices, kits, methods and computer-readable media as set forth in the appended claims, singly or in any combination, thereby attempting to mitigate, alleviate or eliminate the above-mentioned One or more deficiencies, shortcomings or problems in the prior art.

Embodiments of the present invention take advantage of a better understanding of the pumping action of the left ventricle and the close relationship between the coronary sinus (CS), great cardiac vein (GCV) and mitral valve (MV). Embodiments of the present invention provide movement of the coronary sinus and great cardiac vein, thereby moving the mitral valve toward and/or away from the apex along the long axis of the left ventricle (LV) synchronously with the cardiac cycle. Energy for this assisted movement is provided in some embodiments. Embodiments of the permanent implants described herein do not take over or replace the remaining left ventricular pumping function, but rather these embodiments provide an at least partially enhanced upward and/or Or downward movement to strengthen, improve, enhance or support the remaining natural pumping function, the mitral valve acts as a blood displacement or propulsion piston.

The present invention is based on recent knowledge of the workings of the left ventricle, and additionally on the undiscovered favorable anatomy of the left heart. Embodiments of the devices, systems, and methods described herein incorporate modern catheter technology.

Modern imaging of the beating heart has greatly improved understanding of the pumping action of the left ventricle. The pumping force of the left ventricle was previously thought to be the result of the contraction of the heart muscle and the pressure (during systole) on the blood enclosed in the left ventricle after the mitral valve closes, thus increasing the pressure, thereby pushing blood toward the aortic valve, forcing the aortic The valve opens to eject blood into the ascending aorta. When the squeeze is complete, the heart pauses (diastole), during which a portion of new blood flows from the left atrium into the left ventricular cavity.

Ultrasound imaging and magnetic resonance imaging (MRI) showed that the previously taught functional patterns were not entirely correct. Instead, two types of pumping movements can be described: long-axis movements and short-axis movements. Magnetic resonance imaging can show that the plane of the atrioventricular mitral valve (MV) moves downward along the long axis of the left ventricle extending from the atrium to the lower end (apex) of the ventricle. Left ventricular myocytes pull the entire mitral valve plane, including the mitral annulus and a portion of the left atrial wall (which is elongating), toward the apex. By pushing the closed mitral valve towards the apex of the heart, the mitral valve becomes a piston in a blood displacement pump.

The mitral valve moves down a distance of up to about 2 centimeters in a healthy person. The downward movement of the mitral valve accelerates the continuous movement of the blood column away from the left atrium and towards the aortic valve. With the help of magnetic resonance imaging, it is possible to actually mark individual pixels in the blood column and track the movement of the blood column. It can be shown that the blood column flows more or less continuously from the left atrium to the ascending aorta and never stops. The mitral valve piston, moving up and down the long axis of the heart, accelerates the blood column, the mitral valve opens whenever new blood is brought to the atria during its upward motion, and closes just before returning to the apex.

The inventors of the present application recognized that the location of the coronary sinus (CS) and great cardiac vein (GCV) in close proximity to the mitral valve could serve to enhance left ventricular pumping. For example, downward movement of the mitral valve generally along the long axis of the left ventricle may be supported. The mitral valve can be simultaneously moved in the same direction by actively moving the coronary sinus and great cardiac vein down towards the apex, or by supporting the still existing natural heart motion.

The coronary sinus and the great cardiac vein represent the great veins of the heart. Blood from the arteries of the heart flows through capillaries (the smallest blood vessels of the heart) and into the venous plexus in the tissue wall of the heart. The venous blood then flows together into veins that lie on the surface of the heart. On the distal side, the cardiac veins are smaller but merge together into larger and larger veins that then drain into the great cardiac vein and coronary sinus. All venous blood from the heart continuously flows into the coronary sinus and then through the ostium (hole) of the coronary sinus into the right atrium (RA) on the right side of the heart.

Most of the coronary sinus and part of the great cardiac vein lie on the left atrial side of the mitral annulus. Here is the part of the left atrial wall that elongates in a healthy heart as the mitral valve moves down toward the apex. The great cardiac vein then runs across the mitral plane and mitral annulus to the left ventricular side and joins the anterior interventricular vein on the anterior side of the heart. The coronary sinus and the great cardiac vein thus surround at least 2/3 of the mitral valve circumference approximately in the same plane as the mitral valve plane, and are attached or embedded in tissue adjacent to the mitral valve.

Because the ostium of the coronary sinus is on the right side of the heart in the right atrium, the coronary sinus, the great cardiac vein, and its collaterals on the surface of the heart are easily accessed by puncturing a peripheral vein (eg, in the groin of the neck or arm). With modern catheter-based technology, various embodiments of the devices disclosed herein can be placed adjacent to the mitral valve without major heart surgery. In fact, as is customary with pacemaker and intracardiac defibrillator (ICD) implants, the device can be inserted with only local anesthesia while the patient is conscious.

One aspect of the present invention provides a medical device for enhancing intracardiac blood circulation of a patient's heart by continuously assisting the pumping action of the left ventricle. The device has at least one first anchor unit implanted in a cardiac vessel, such as a coronary sinus (CS) or a collateral of the great cardiac vein (GCV). The first anchor unit may be an expandable stent structure for anchoring the anchor unit in a cardiac vessel and/or wherein the first anchor unit has at least one tissue anchoring element such as a hook or barb.

In various embodiments, the device has at least one second anchor unit implanted in a cardiac vessel, wherein the second anchor unit is located in the coronary sinus or the great cardiac vein. The second anchor can be used to transmit force from the remote force generating unit.

Accordingly, the device has a force generating unit in communication with the first and second anchor units, wherein the force generating unit generates a force according to the cardiac cycle of the heart. The anchor unit receives the force so as to provide assisted movement of the cardiac vessels in a direction towards and/or away from the apex of the heart and thus provide assisted movement of the mitral valve in the mitral valve plane. assisted movement. However, in a specific embodiment, the second anchor unit can also have an integrated electric motor and the force generating unit is this motor, said device has a connection unit between the motor and the first anchor for said connection, and The power is provided by the motor. Accordingly, the integrated electric motor is powered by a remote energy source via the cable.

With the force applied, the mitral valve is assisted during systole to move the mitral plane along the long axis of the left ventricle (LV) toward the apex and/or during diastole to move the mitral plane toward the apex. away from the apex of the heart to assist the heart's pumping action. Assisted motion is provided in a controlled manner to support the natural motion of the mitral valve. When mitral valve movement towards the apex is at least partially assisted during systole, the (still existing) natural pumping force of the heart is enhanced while ejecting blood into the aorta. Supports the natural filling of the left ventricle of the heart when at least partially assisting mitral valve motion away from the apex during diastole. Thus, the natural pumping function of the (still existing) heart is enhanced by increased filling. The force generating unit is operably connected to the remote energy source to receive energy from the remote energy source and controllably provide assisted motion in synchronization with the natural heart cycle.

In some embodiments, the force generating unit is an actuation unit for providing said force as a mechanical force, and wherein the first anchor unit and the actuation unit are connected via a connection unit in order to transmit force and provide motion.

In some embodiments, the force is a magnetic unit for providing said force as a magnetically induced force. In such embodiments, both anchors are magnetic, and wherein a first magnetic anchor unit in the coronary sinus or great cardiac vein is in magnetic communication with a second magnetic unit to transmit force and provide motion. At least one magnetic anchor unit is an electromagnet. At least one of the electromagnets is arranged to change polarity synchronously with the cardiac cycle. While the second electromagnet anchor is always located in the coronary sinus or the great cardiac vein, the first magnet can be located in various locations. In some embodiments, the first magnet is located within a side branch of the venous system on the wall of the left ventricle (such as an IAV), the first magnet can also be located in the left ventricle and attached to the wall of the left ventricle, or located in the right ventricle, the right atrium of the heart Either in the left atrium, or on the outer wall of the left ventricle of the heart. In other embodiments, the first magnetic anchor may not be located in the heart, but adjacent to the heart, for example on the pericardium, septum, spine or thorax, in the pleura, or under the skin.

In some embodiments, the device has a remote energy source, a control unit, and sensors for measuring physiological parameters related to cardiac cycle activity and providing sensor signals. The sensor signal is provided to a control unit which controls the force generating unit to provide motion based on the sensor signal using energy from a remote energy source. The remote energy source may have a mechanical part that produces rotational or linear motion. The device may further have an extension unit extending from the mechanical part, wherein the mechanical part is a force generating unit, and wherein, in operation of the mechanical part, the movement is transmitted to the first and second anchor units via the extension unit, In order to obtain the motion of the mitral valve plane. The control unit controls the remote energy source to provide electrical energy to: (a) one or more electromagnetic anchor units attached to the mitral valve, or (b) at least one force generating unit disposed at or in the heart, thereby providing mitral Movement of the flap plane.

In another embodiment, a first anchor unit may be implanted in the great cardiac vein or its continuation, more specifically the anterior interventricular vein (AIV), and the second anchor unit may be implanted in the coronary sinus. An elongated extension unit connects the first and second anchor units in a ring such that they are in mechanical communication. Thus, the portion of the device within the coronary sinus and the great cardiac vein geometrically forms an annulus that surrounds 2/3 of the mitral valve and is very close to the mitral valve. the extension unit extends proximally beyond the second anchor unit to a mechanical actuator unit arranged to rotate the extension unit synchronously with the cardiac cycle, wherein the device has different operating positions when the extension unit rotates, including a diastolic operating position when the extension unit is rotated in a first direction, wherein the annular extension unit bends toward the left atrium and the coronary sinus, great cardiac vein, and mitral valve move toward the left atrium; and when the extension unit is in the A second operational position when rotated in a second direction opposite to the first direction, wherein the annular extension unit bends toward the left ventricular apex and the coronary sinus, great cardiac vein, and mitral valve move toward the left ventricular apex.

In some embodiments, the device is an unpowered device. The force generating unit may be an elastic unit, and the first anchor unit may include a distal anchor unit. The distal and proximal anchor units may be placed in the anterior interventricular vein, the coronary sinus, and the great cardiac vein. The elastic unit may be a ring connecting the distal anchor unit and the proximal anchor unit, wherein the elastic unit has a relaxed position in an upper mitral valve plane position that is spring loaded against a mitral valve infraplane position such that Myocardial force of the left ventricle brings the annulus to the down position, and the elastic unit assists in diastolic filling of the left ventricle by pushing the open mitral valve upward against blood flow further in the direction of the left atrium, thereby auxiliary. In other embodiments, said elastic unit has a relaxed position in said inferior mitral valve plane position, which is spring loaded against said mitral valve plane position, such that the diastolic tension of the left ventricle will The annulus is brought to the upper position and the elastic unit assists in systolic contraction of the left ventricle by pushing the closed mitral valve down towards the left ventricular apex.

An integrated bioresorbable material such as PLLA, polyethylene, or polylactide may initially be used to lock the elastic unit so that the spring-loading action first begins when the resorbable material has been at least partially resorbed, so that when implanted The device has delayed activation.

According to another aspect of the present invention, there is provided a kit for sustainably enhancing or enhancing the pumping function of the left ventricle of a heart. The kit comprises: an implantable cardiac assist device according to the first aspect of the invention and a delivery system suitable for inserting the assist device into a patient and comprising a guide wire, a guide catheter and an introduction catheter.

According to another aspect of the present invention, there is provided a kit for sustainably enhancing the function of the left ventricle of a heart. The kit includes: a left ventricular augmentation or augmentation system that is placed in the coronary sinus and adjacent tissue to enable the mitral valve plane, its annulus and leaflets to move in the direction of the long axis of the left ventricle in synchrony with the electrocardiogram; an energy source; and A delivery system for carrying the augmentation system to a desired location in the heart.

The kit provides a package for surgeons who intend to introduce augmentation systems into patients. Thus, the kit provides an implant that can be used to continuously treat a patient, and a delivery system that can be used to insert the implant. The augmentation unit can be stored mounted in the delivery system, while the energy source can be packaged separately for connection during surgery. The kit may also include a guide wire to guide insertion of the delivery system through the patient's vasculature to a desired location. The delivery system may also include a guide catheter arranged to be advanced over the guidewire to a desired location. In addition, an introduction catheter for establishing access to the vascular system through the energy source pocket is part of the kit. The introduction catheter includes a valve that stops blood from flowing back but still allows the wire or guide catheter to pass through.

According to yet another aspect of the present invention, there is provided a method for continuously enhancing intracardiac blood circulation in a patient's heart by assisting the pumping action of the left ventricle. The method includes: generating a force according to the cardiac cycle of the heart by means of a force generating unit; applying the force to an implant in a cardiac vessel close to the mitral valve of the heart and connected to the mitral valve tissue of the heart so as to move along the and/or a direction away from the apex of the heart obtains assisted motion of the cardiac vessels and thus of the mitral valve in the mitral valve plane.

Assisted motion may include controlled movement of the mitral valve by force in the plane of the mitral valve generally along the long axis of the left ventricle of the heart.

In some embodiments, the aforementioned controlled movement may include moving a mitral valve in the heart in reciprocating motion toward the apex during systole and away from the apex during diastole to assist the pumping action of the heart.

Generating force according to the heart's cardiac cycle may include: detecting the heart's natural motion (eg, by measuring the heart's electrocardiogram, blood pressure waves, blood flow, or acoustic signals); and providing energy to displace the mitral valve in synchronization with the natural heart cycle. The natural upward and downward motion of the mitral valve is thereby assisted during the heart cycle.

In another embodiment, the assisted movement may comprise controlled movement by the force of the mitral valve in the plane of the mitral valve approximately along the long axis of the left ventricle of the heart additionally in the short axis of the left ventricle.

In some embodiments, this additional lateral controlled movement may include moving the left ventricular sidewall in the heart in reciprocating motion toward the interventricular septum of the heart during systole and away from the interventricular septum during diastole to follow the The short axis of the left ventricle assists the pumping action of the heart.

Force generation according to the heart's cardiac cycle may include: detecting the heart's natural motion (for example, by measuring the heart's electrocardiogram, blood pressure waves, blood flow, or acoustic signals); and providing energy to displace the mitral valve in synchronization with the natural heart cycle . Thereby, the natural upward and downward motion of the mitral valve and the natural inward and outward motion of the left ventricular sidewall along the short axis of the left ventricle relative to the interventricular septum are assisted during the heart cycle.

According to yet another aspect of the present invention, a method for sustainably treating left ventricular failure in a patient is provided. The method includes: inserting a left ventricular augmentation system into the coronary sinus and adjacent veins and tissue; and positioning the augmentation unit at a desired location such that the augmentation unit is connectable to an energy source device.

The method includes delivering external energy to the augmented units in the coronary sinus and the great cardiac vein to move the mitral valve up and down in an axial direction from the left atrium toward the left ventricular apex in synchronization with the natural heart cycle.

The method also includes inserting an energy source under the skin. This method allows the connection of a cable or device extension for delivering power to an energy source located under the skin but outside the vein.

In addition, the method involves passing electrical energy through the skin via cables or electromagnetically so that the electrical energy is stored in batteries under the skin.

Additionally, the method includes utilizing a computer chip and algorithm to detect a spontaneous cardiac cycle and directing the augmentation device based on the cardiac cycle obtained by the device detecting the electrocardiogram.

The preferred method of placing the energy source would be by surgery through a small incision in the skin and making a small pocket in the subcutaneous tissue beneath the skin. Part of the method will be to use the same pocket to gain access to the vein by piercing the same pocket through the introducer catheter into the vein. A further part of the method will be to gain access to the interior of the left heart by puncturing the artery for anchor placement. Additionally, as part of the method, the anchor is attached to the atrial septum in the naturally continuous foramen ovale, or the anchor is attached to the atrial wall with a hook. Finally, hooks can be used to attach the anchor to the inside of the ventricle or atrium.

In some embodiments, the method may comprise: inserting a solid anchor unit of an implantable heart assist device according to the first aspect of the present invention into the coronary sinus and/or adjacent veins and tissues; placing the force generating unit in The location of the anchor unit is remote so as to provide reciprocation of the mitral valve along an axis extending from the left atrium to the apex of the left ventricle of the heart.

Yet another aspect of the present invention provides a medical procedure comprising delivering a medical device adapted to enhance intracardiac blood circulation of a patient's heart by assisting the pumping action of the left ventricle. This step may comprise: providing a medical system comprising the medical device of some embodiments of the first aspect of the invention with external energy provided therein; providing a source of energy; and minimally invasively delivering said medical system inside a patient.

This step may comprise: providing a delivery system (such as the aforementioned kit for minimally invasively delivering a medical device within a patient); minimally invasively delivering a force generating unit of a medical system within a patient by means of the delivery system; delivering energy source; and connecting the energy source and the force generating unit.

This step may include: using a delivery system comprising an introduction catheter with a valve, a guide catheter, and a guide wire; and introducing the introduction catheter into the patient's vasculature at the puncture site; inserting the guide wire into the vasculature via the introduction catheter; passing the guide catheter through the vasculature and The heart is navigated to the desired site; a guide catheter is inserted over the guidewire; the guidewire is withdrawn; the first anchor unit is delivered a distance from the mitral valve and the second anchor unit is delivered through the guide catheter to the mitral valve.

According to still another aspect of the present invention, there is provided a computer readable medium having thereon a computer program for processing by a computer. The computer program includes code segments for controlling a medical device for continuously enhancing the intracardiac blood circulation of a patient's heart by assisting the pumping action of the left ventricle. The code segment is configured to control the force generating unit to generate a force according to the cardiac cycle of the heart, so as to apply the force to an implant in a cardiac vessel proximate to the mitral valve of the heart and connected with the mitral valve tissue of the heart, so as to move along Assisted motion of the cardiac vessels and thus of the mitral valve in the mitral valve plane is obtained in a direction towards and/or away from the apex of the heart.

Other embodiments of the invention are defined in the appended claims, wherein the second and subsequent aspects of the invention are characterized mutatis mutandis to the first aspect.

It should be emphasized that the term "comprising/comprising" used in this specification refers to the presence of stated features, integers, steps or components, but does not exclude the presence of one or more other features, integers, steps, components or groups thereof or add.

Description of drawings

These and other aspects, features and advantages of embodiments of the invention will become apparent based on the following description of the embodiments of the invention and with reference to the following drawings.

Figures 1a and 1b are schematic diagrams of the human heart depicting the relevant cardiac anatomy.

Figures 2a and 2b are schematic illustrations of the anatomy of the cardiac venous system including the coronary sinus, great cardiac vein and collaterals, and the level of the mitral valve plane relative to the axis of the left ventricle.

3 and 4 are schematic diagrams explaining the normal motion of the cardiac venous system and the mitral valve during a normal cardiac cycle.

Figures 5-9 are diagrams schematically describing how the present invention may utilize different embodiments to enhance mitral valve motion.

10-12 are schematic diagrams depicting different embodiments of using pulling and pushing forces to enhance mitral valve motion.

13-16 are schematic diagrams depicting different embodiments of using rotational force to enhance mitral valve motion.

Figure 17 is a schematic diagram showing a remote energy source.

18-20 are schematic diagrams showing delivery systems.

21-24 are schematic diagrams explaining a method for delivering an augmentation system.

Figure 25 is a flowchart of the method.

Detailed ways

Now, specific embodiments of the present invention will be described with reference to the accompanying drawings. However, this invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will incorporate the present invention Ranges are fully expressive to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the drawings is not intended to be limiting of the invention. In the drawings, the same reference numerals refer to the same elements.

Embodiments of the present invention take advantage of the novel discovery of the proximal relationship between the pumping action of the left ventricle and the coronary sinus (CS), great cardiac vein (GCV), and mitral valve (mitral valve). With the aid of external power, some embodiments are able to provide movement of the coronary sinus and great cardiac vein, thereby providing movement of the mitral valve along the long axis of the left ventricle (LV) toward the apex synchronously with the cardiac cycle. The permanent implants described herein do not take over or replace the remaining left ventricular pumping function, but instead enhance the pumping function with increased upward and/or downward motion of the mitral valve plane relative to the long axis of the left ventricle.

Turning now to the drawings, Figures 1a, 1b, 2a and 2b depict the structure of a heart 1, at least some of which is relevant to embodiments of the present invention. 2 is the superior vena cava (SVC), 4 is the right atrium (RA), 6 is the ostium of the coronary sinus, 8 is the first part of the coronary sinus (the rest of the coronary sinus is behind the heart, as depicted in Figure 1b), 10 is the inferior vena cava (IVC), 12 is the great cardiac vein (GCV) at the level of the mitral annulus 18, 14 is the left atrial cavity (LA), 16 is the wall of the left atrium, 18 is the mitral annulus, and 19 is The entire mitral valve, 20 is the anterior leaflet of the mitral valve, 21 is the posterior leaflet of the mitral valve, 22 is the muscular wall of the left ventricle, 24 is the papillary muscle, 26 is the apex of the left ventricle, 28 is the aortic valve, and 30 is the ascending Aorta, 32 is the interventricular muscle septum, 34 is the left ventricular cavity, 36 is the right ventricular cavity, 38 is the right ventricular muscle wall, and 40 is the tricuspid valve.

Figures 1b and 2a show schematic diagrams depicting the venous system of the heart, where reference numeral 42 is the anterior interventricular vein, 44 is the lateral vein (a side branch in the outer wall of the left ventricle), and 46 is the posterior descending vein. These collateral veins are also often called left marginal veins, posterior left ventricular veins, or cardiac veins. However, these collateral veins are collaterals of the coronary sinus or the great cardiac vein, regardless of what they are called in the literature.

The mitral valve plane 48 shown in FIG. 2 b is related to the venous system and the left ventricular long axis 49 , which is approximately perpendicular to the mitral valve plane 48 .

Figure 3 is a diagram of the mitral valve plane 48 relative to the left ventricular apex 26, the great cardiac vein 12 (and the coronary sinus), the anterior and posterior leaflets 20 and 21 of the mitral valve, and the mitral annulus 18 during normal heart beating. , a schematic diagram of the motion of the aortic valve 28 , the left atrial wall 16 and the left atrial cavity 14 . The large arrow x shows the direction of blood flow and the small arrow y shows the direction of motion of the mitral valve plane 48 , the great cardiac vein and the coronary sinus until reaching the end-systolic position ("down" position). Figure 3 shows the following moments in the cardiac cycle: (a) just before systole, (b) during systole, and (c) end systole.

Referring to FIG. 4 , the mitral valve plane 48 is shown relative to the left ventricular apex 26, great cardiac vein 12 (and coronary sinus), anterior mitral valve leaflet 20, and posterior leaflet 21 during diastole during a normal heartbeat. , a schematic diagram of movement of the mitral annulus 18, aortic valve 28, left atrial wall 16, and left atrial cavity 14. The large arrow x shows the direction of blood flow and the small arrow y shows the direction of motion of the mitral valve plane 48 , the great cardiac vein and the coronary sinus until the end-diastolic position ("up" position) is reached. The following moments in the cardiac cycle are shown in Figure 4: (a) early diastole, (b) late diastole, and (c) end diastole, where the mitral valve is now closed and ready to descend in the following systole. One downward motion.

FIG. 5 is a schematic diagram of an embodiment when a medical device for cardiac assistance is inserted into the heart 1 . Some embodiments, such as the inventive device, have two anchor units. The first anchor unit 50 is located in the coronary sinus 8 and/or the great cardiac vein 12 . The second anchor unit 52 is located away from the first anchor unit. The second anchor unit 52 is arranged eg in a side branch of the venous system on the wall 22 of the left ventricle. The two anchors 50, 52 are interconnected. As shown, the two anchors are connected by means of a push-pull unit 54 which can move the two anchors relative to each other. As shown in FIG. 3, the diagram depicts the mitral valve plane 48 relative to the left ventricular apex 26, the great cardiac vein 12 (and the coronary sinus), the anterior leaflet of the mitral valve during the systolic phase of a boosted or assisted heart beat. 20 and posterior leaflet 21, mitral annulus 18, aortic valve 28, left atrial wall 16 and left atrial chamber 14 motion. A push-pull unit 54 powered by a powered unit (not shown, such as a remote or external powered unit) brings the two anchors closer to each other, thereby enhancing the force and extent of the downward movement of the mitral valve 19 . This assists the pumping action of the left ventricle. Large arrows (x) show the direction of blood flow and small arrows (y) show the direction of the mitral valve plane, great cardiac vein, and coronary sinus. The following moments in the cardiac cycle are shown in FIG. 5 : (a) just before systole, (b) during systole, and (c) end systole.

Figure 6 is a schematic illustration of an embodiment of the invention when inserted into the heart 1 . One anchor 50 of the two anchors is located in the coronary sinus 8 or the great cardiac vein 12 and the other anchor 52 is located in a side branch of the venous system on the wall 22 of the left ventricle. The two anchors are connected by means of a push-pull unit 54 which can move the two anchors relative to each other. Figure 4 shows the mitral valve plane 48 relative to the left ventricular apex 26, great cardiac vein 12 (and coronary sinus), anterior and posterior leaflets 20 and 21 of the mitral valve, mitral Movement of the annulus 18, aortic valve 28, left atrial wall 16 and left atrial chamber 14; the push-pull unit 54 powered by a remote or external power unit 84 (not shown) moves the two anchor units away from each other. When the two anchors are fixed in the tissue they anchor, the tissue structure moves with the anchor unit. The anchor unit thereby reinforces the force and extent of the upward movement of the mitral valve 19 towards the left atrium. Thus, the device enhances diastolic filling of the left ventricle before the next heart beat. Thus, cardiac assistance is provided even during diastole. The large arrow x shows the direction of blood flow and the small arrow y shows the direction of the mitral valve plane 48, the great cardiac vein and the coronary sinus. The following moments in the cardiac cycle are shown in Figure 6: (a) early diastole, (b) late diastole, and (c) end diastole, when the mitral valve is now closed and ready for the next downward movement.

The use of a linear accelerator and a computer constitutes an example of the invention. The computer makes it possible to synchronize the movements with the EKG. This paradigm was tested in animal experiments. Open the breast of a 60 kg pig between the ribs. A rod from a linac was attached to the mitral annulus from outside the heart. Drugs that suppress heart function. After activation of the device, an increase in arterial blood pressure and cardiac output was observed.

Figure 7 is a schematic view of another embodiment of the invention when inserted into the heart 1 . The device has two anchor units. The first anchor unit 56 is located in the coronary sinus 8 and/or the great cardiac vein 12 . A second, remote anchor unit 58 is located on the left ventricular wall 22 or within a side branch of the venous system attached to the left ventricular outer wall. Here, the two anchors are magnets. Preferably, the two anchors take the form of electromagnets, but one or the other magnetic anchoring unit may also be a conventional permanent magnet. The electromagnets are arranged to change polarity synchronously with the heart cycle, changing between pulling towards each other and pushing away from each other. There are no physical connection units between the magnetic anchor units. These anchor units are only in magnetic connection. When the two anchoring units have different polarities, the two anchors are brought closer to each other, and correspondingly, when the polarities are the same, the two anchors are moved away from each other. As shown in FIG. 3 , FIG. 7 depicts the mitral valve plane 48 relative to the left ventricular apex 26, the great cardiac vein 12 (and the coronary sinus), the anterior leaflet 20 of the mitral valve during an enhanced heart beat. and posterior leaflet 21, mitral annulus 18, aortic valve 28, left atrial wall 16, and left atrial chamber 14. The magnetic anchors 56 and 58 attract each other and use magnetic force to bring the two anchors closer to each other, thereby enhancing the force and extent of the downward movement of the mitral valve 19 . The large arrows show the direction of blood flow and the small arrows show the plane of the mitral valve, the great cardiac vein and the coronary sinus and the direction of the magnet 56 . The following moments in the cardiac cycle are shown in Figure 7: (a) just before systole, (b) during systole, and (c) end systole.

Figure 8 is a schematic diagram of the same embodiment as Figure 7 in diastole. The first anchor unit 56 is located in the coronary sinus 8 and/or the great cardiac vein 12 . The second anchor unit 58 is located away from the first anchor unit 56 . Here, the second anchor unit is located inside a side branch of the venous system on the wall 22 of the left ventricle. Alternatively or additionally, a second anchor may be attached to the left ventricle outer wall. The two anchors are magnets (preferably electromagnets), but one or the other anchor may also be a conventional permanent magnet. The electromagnets can change polarity synchronously with the heart cycle, changing between pulling toward each other and pushing away from each other. There is no physical connection to the unit. The two anchoring units are brought closer to each other when they have different polarities, and correspondingly moved away from each other when the polarities are the same. As shown in FIG. 4, FIG. 8 depicts the mitral valve plane 48 relative to the left ventricular apex 26, great cardiac vein 12 (and coronary sinus), anterior leaflet 20 of the mitral valve during diastolic phase during an enhanced heart beat. and posterior leaflet 21, mitral annulus 18, aortic valve 28, left atrial wall 16, and left atrial chamber 14. The magnetic anchors 56 and 58 are now of the same polarity (either negative or positive at the same time) and will push each other away, thus pulling the two anchors away from each other by means of the magnetic force, thereby increasing the force and force of the upward movement of the mitral valve 19 degree. The large arrows show the direction of blood flow and the small arrows show the plane of the mitral valve and the direction of the magnet 56, the great cardiac vein and the coronary sinus. The following moments in the cardiac cycle are shown in Figure 8: (a) early diastole, (b) late diastole, and (c) end diastole.

An alternative positioning of the second magnetic anchor unit 58 is shown in FIG. 9 . The second anchor unit 58 may be an electromagnet or a permanent magnet. The second anchor 60 may be an electromagnet or typically a permanent magnet. While the second anchor 58 is a permanent magnet, the first magnetic anchor 56 is an electromagnetic unit having a selectively activatable magnetic polarity. The second anchor 58 can be placed at various locations in the heart. However, it is also possible in some embodiments to place the second anchor 58 outside the heart. Location 61 represents where the second anchor 58 is not attached to the heart or where it is attached in the heart. One such location is in the pericardium. Another location is in the pleura or under the skin. Possible attachment sites include pericardium, septum. The spine or thorax (ribs and sternum) are also suitable sites for attachment of the second anchor 58 . The positions 62, 64, 66, 68 represent the position of the second magnetic anchor 58 relative to the heart. Location 62 is in the left ventricle and location 64 is in the right ventricle. The location 66 is located in the right atrium, preferably in the so-called atrial septum between the right atrium and the left atrium. A good location is in the foramen ovale of the atrial septum, where there is often an opening in the left atrium. In this embodiment, the second anchor unit may have the shape of a septal occluder and provide septal leak occlusion and allow support of heart function. Location 68 indicates a location in the left atrium, further a good attachment site would be the atrial septum, another good location in the left atrium would be the left atrial appendage (LAA, not shown). In this embodiment, the second anchor unit may have the shape of a left atrial appendage occluder and provide occlusion of the left atrial appendage and allow support of heart function. These are merely examples, and a person skilled in the art can envisage many variations that also achieve this purpose.

Another embodiment of providing support or assisting force by means of a micromotor 70 integrated into the coronary sinus anchor and/or the great cardiac vein anchor is shown in Fig. 10a. MEMS (Micro Electromagnetic Systems) technology can be used to manufacture such motors. One or more second anchor units 72 are disposed in the one or more side branches 44 to which the connection unit 54 is attached.

The permanent magnets in various embodiments may be conventional magnets. Alternatively, when the system includes magnetic elements, super strong magnets such as neodymium rare earth magnets may be utilized to increase efficiency and/or reduce the size of the units of the cardiac assist system.

The anchor unit may take the form of a stent, for example. Stents are used as anchors in blood vessels. Such a stent may be, for example, a self-expanding stent made of a shape-memory material, such as a shape-memory metal, such as superelastic Nitinol. The micromotor 70 can then be integrated into a bracket structure (not shown). The stent may also be a stent having a structure that must be expanded with a balloon, or a stent made of a material such as stainless steel or another metal suitable for this purpose. Alternatively or additionally, the anchor unit is made with a hook that pokes into tissue made of a similar material, these are just examples and a person skilled in the art, on reading this specification, will be able to imagine a variety of methods that also achieve this purpose. Variety. Accordingly, the motor 70 is attached to the vascular structure. The motor 70 may be attached to the vessel structure using stent technology and/or using hooks, and those skilled in the art will find various solutions. However, all these solutions are usually implemented by puncturing a blood vessel (preferably a vein) through the skin and using catheter technology.

Multiple sets of motors 70, anchors 72 and connection units 54 may be simultaneously implanted and connected to one or more energy sources 84 (not shown), as shown in Figure 10b. A remote energy source 84 utilizes the insulated electrical cable 74 to provide electrical power for the micromotor.

In yet another embodiment shown in FIGS. 11 a and 11 b , a remote energy source 84 mechanically delivers energy for movement of the mitral valve plane 48 . This mechanical force may be provided via an elongated connection unit 54 such as a wire or an elongated flexible rod. Motion is transmitted to the anchor unit 72 through the coronary sinus or great cardiac vein anchor 76 by a mechanical actuator, eg, located at a remote energy source. The anchor unit 76 may have a guide unit 80 for the connection unit 54 for transferring the mechanical movement from the anchor 76 to the side branches 44 of the venous system used. The guide sheath 78 may be fixed in the anchor 76 and the energy source 84 such that when pulled relative to the guide sheath 78 in the connection unit 54 by a mechanical actuator (eg, located at the energy source), the distance between the anchor 72 and the anchor 76 distance will be shortened. Accordingly, the distance between the two anchors 72 and 76 increases when the connection unit is advanced in the remote energy source. The guide unit may also be a mechanical unit that transmits a longitudinal movement (or a rotational movement, see below) to a movement in a direction perpendicular to the unit 54 . Thus, upward and downward reciprocating cardiac assist motion of the mitral valve plane 48 is provided.

Turning to FIG. 11 b , there is shown an embodiment of the type described in FIG. 11 a except that for the coronary sinus or great cardiac vein anchor 82 there is an anchor design equal to one in the side branch 44 . In this way, the efficiency of the heart assist device can advantageously be increased. In long-term use of the device, a geometric distribution of support forces may be provided that is favorable to cardiac structures.

Figures 12a and 12b show an example of the configuration described in Figures 7, 8 and 9, where electromagnets are used as anchors. Different combinations of electromagnets and typical permanent magnets will not be depicted in the respective figures, as they will be apparent to those skilled in the art when reading this application. In Figure 12a, the first anchor is located in the coronary sinus or a collateral 44 of the great cardiac vein and in Figure 12b in the anterior interventricular vein (AIV).

Yet another embodiment of the present invention is depicted in FIGS. 13 , 14 , 15 and 16 . Instead of pushing and pulling the extension unit 54, the rotation of the extension unit 54 is used to transmit the mechanical force. Now, the distal anchor 73 of the device is not located in the side branch. Instead, the distal anchor 73 is placed in the anterior interventricular vein 42 in the distal great cardiac vein 12 or its continuation. This embodiment takes advantage of the fact that the three-dimensional shape of the coronary sinus and great cardiac vein represents a loop from the back of the heart near the left corner of the heart to its anterior surface. The ring is generally oriented in the mitral valve plane 48, as shown in Figure 2b. The extension unit 54 is an elongated annular unit whose distal end terminates in the distal anchor unit 73, where the extension unit 54 is attached to the distal anchor unit 73, as shown in Figs. 15a-c. Accordingly, the coronary sinus and/or the great cardiac vein may be moved in a direction toward and/or away from the left ventricular apex 26 by appropriate actuation of the annular extension unit 54 . Because myocardial tissue connects the mitral valve to the coronary sinus and great cardiac vein, motion of the extension unit 54 is transmitted to the mitral valve plane 48 .

The portion of the extension unit 54 located inside the coronary sinus and the great cardiac vein is depicted in FIG. 13 , here indicated by 55 . The device has different operating positions, as shown in Figures 13a-c. In the middle position, as shown in Figure 13a, we can see a vertical view of the ring, from which the ring appears as a straight line. In addition, a comparison is also made with the view in Fig. 15a.

The distal anchor unit 73 is located in front of the heart. The most preferred distal anchor unit 73 is made using a stent design. In the great cardiac vein or preferably in the coronary sinus, the second anchor 75 is placed proximal to the distal anchor 73 as close as possible to the ostium 6 ( FIG. 1 ). The second anchor is preferably made using a stent design. Another anchor 77 may be located anywhere between the distal anchor 73 and the proximal anchor 75, as shown in FIG. 14 . Preferably, the anchor 77 is made using a stent design.

The extension unit 54 is connected proximally to a mechanical actuator that controllably rotates the extension unit 54 in synchronization with the cardiac cycle. In this embodiment, the extension unit 54 is connected proximally to a remote energy source 84 . However, in other embodiments, other arrangements and locations of mechanical actuators that cause rotational movement of the elongated extension unit 54 may be provided. A mechanical actuator may be placed, for example, within the heart.

When the extension unit 54 is rotated in the clockwise direction (viewed from the direction of the mechanical actuator, here is the end of the remote energy source 84), as shown in position b of FIG. The coronary sinus and great cardiac vein move in this direction. Because the coronary sinus and the great cardiac vein are also close to the mitral valve, this backward motion during diastole relative to the left ventricular apex will reinforce the normal upward motion of the mitral valve if clockwise rotation is performed during diastole.

Similarly, a counterclockwise rotation during systole will enhance the downward movement of the closing mitral valve (piston) during systole, as in position c) in Fig. 13.

Also shown in FIG. 14 is the additional presence of a retaining unit 79 that longitudinally locks the extension unit 54 in place at the proximal anchor unit 75 . This retaining unit, which may be a tube or a ring in the anchor, will allow extension 54 to rotate, but will resist axial movement thereby preventing misalignment of extension units 54 and 55 . The extension units 54 and 55 may be in one integral part or have different sections that are hinged (not shown). The number and connection of the segments can be chosen appropriately in order to engineer the stiffness and flexibility necessary to hold the device in place while still functioning.

Figure 15 shows in more detail an embodiment that takes advantage of rotating the ring in an anatomical environment. Figure 15a depicts the intermediate position. In Fig. 15b, the extension units 54 and 55 are rotated clockwise. Now, in diastole, the annulus of the extension unit 55, the coronary sinus, the great cardiac vein and the mitral valve move upwards towards the left atrium. In Fig. 15c, during systole, extension units 54 and 55 are rotated in a counterclockwise direction and the annulus, coronary sinus, great cardiac vein and mitral valve of extension unit 55 are moved downward towards the left ventricular apex.

The direction of mitral valve plane motion (here related to rotation) is controlled synchronously with the cardiac cycle, eg based on ECG detection. A control unit operable to effect control is provided, as described in one embodiment below. The control unit is applicable to the remote energy source unit 84 .

Furthermore, in another embodiment, a longitudinal movement of the extension unit 54 may be added in addition to the rotational movement. By pushing the extension unit 54 attached to the distal anchor 73 against the sheath 78 (now fixed to the proximal anchor 75), the distance between the anchor 73 and the anchor 75 can be shortened. In some embodiments, this additional lateral controlled movement may include moving the left ventricle of the heart in reciprocating motion toward the interventricular septum of the heart during systole and away from the interventricular septum during diastole to assist in moving along the heart. The pumping action of the heart in the short axis of the left ventricle. Moving extension unit 54 distally relative to sheath 78 during diastole is shown in Figure 15d in addition to clockwise rotation. Therefore, the length of the connecting extension unit portion between the proximal anchor and the distal anchor is extended. Thus, outward movement of the left ventricular side wall relative to the intraventricular septum is enhanced. On the other hand, during systole, as shown in Figure 15e, in addition to rotating in a counterclockwise direction, the extension unit 54 is moved proximally relative to the sheath 78, thereby drawing the distal anchor 73 more proximally Anchor 75. Therefore, the length of the connecting extension unit portion between the proximal anchor and the distal anchor is shortened. Thus, the inward movement of the left ventricular side wall relative to the intraventricular septum is enhanced. For example, based on ECG detection, the direction of motion of the left ventricular side wall (here related to push and pull in addition to rotation) is controlled synchronously with the cardiac cycle. A control unit operable to perform control is provided, as described in the examples below. The control unit is applicable to the remote energy source unit 84 . Accordingly, the coronary sinus implantation of various embodiments can be adjusted during at least a portion of a single cardiac cycle. Make adjustments while starting. In alternative embodiments, stub-axis supported actuation may be implemented based on other units and actuation principles including electric or magnetic actuators, etc. In addition, the medical device may have a plurality of sections whose lengths are individually adjustable by the actuation unit and which are controlled by said control unit being arranged to individually controllably change the shape of said sections. For example, embodiments of the device of the present invention may include anchoring elements between each of the plurality of sections, wherein each can be adjusted, for example, by pulling or pushing apart the distal and proximal anchoring elements of one section. section length.

The spring intrinsic force utilized in another embodiment is shown in Figures 16a and 16b. Here, the extension unit 55 is inserted into the coronary sinus and the great cardiac vein or the anterior interventricular vein and divided. Preferably, the extension unit 55 in this embodiment has a fixed connection to the distal and proximal anchor units 73 , 75 . The heart assist device is provided in the form of an elastic unit. In this embodiment, the cardiac assist device is placed in a relaxed position in the supra-plane position of the mitral valve. The relaxed position of the unit is spring loaded against the infra-plane position of the mitral valve. The ring 55 of the extension unit 54 has a preset preferred state of a relaxed state. Thus, extending the unit during diastole and systole moves the coronary sinus, great cardiac vein, and mitral valve upwardly towards the left atrium, ie against the spring loaded force. The intrinsic spring loading force is chosen to be less than the mitral plane-down force provided by the left ventricular muscle. Thus, during systole, the myocardial force of the left ventricle will be stronger than the intrinsic spring force of the extension 55 and bring the ring down towards the left ventricular apex during systole. Thus, the device assists in diastole as it increases diastolic filling of the left ventricle by pushing the open mitral valve upward against blood flow further in the direction of the left atrium. On the other hand, the elastic unit may have a relaxed position in the lower mitral plane position, which is spring loaded against the upper position of the mitral plane, so that the diastolic tension of the left ventricle brings the annulus to the upper position, and the elastic unit assists in systole by pushing the closed mitral valve down toward the left ventricular apex to assist in systolic contraction of the left ventricle.

This unpowered device may be made of nitinol, shape memory metal or stainless steel or any other suitable material, preferably metal. In these particular embodiments, the control unit or remote energy unit 84 is omitted. The action can be delayed by integrating resorbable material into the device in order to delay its action and allow the device to grow before its action begins when the resorbable material disappears. This material may be eg PLLA, polyethylene or polylactide or other resorbable material.

Alternatively or additionally, the heart assist system can be configured as a bistable system. Here, the supra-diastolic and sub-systolic positions of the mitral valve plane can be provided as equilibrium states for the system. Power is supplied from external energy or a source of left ventricular muscle to initiate movement of the system between two stable positions. These embodiments are more energy efficient than others.

In various embodiments, the cardiac assist device has a control unit, and sensors for measuring physiological parameters related to cardiac cycle activity and providing sensor signals. The sensor signal is provided to a control unit which controls the displacement unit to provide said movement using energy from the energy source and based on the sensor signal. Thus, heart assist device operation is controlled in synchronization with heart action. The sensors may be ECG electrodes, additionally or alternatively, based on detecting other physiological parameters related to the heartbeat, such as blood pressure waves, blood flow patterns, or the acoustic signal of the heartbeat.

A remote energy source 84 included in some embodiments is shown in FIG. 17 . The remote energy source 84 has a battery section 86, and a computing section 88 containing computer algorithms and chips. The computer portion 88 has associated therewith receiving electrodes or surface 92 capable of detecting electrocardiogram (ECG) signals. In various embodiments, the operation of the cardiac assist device is controlled in synchronization with cardiac motion based on the ECG signal.

Additionally or alternatively, such synchronicity may be established by detecting other physiological parameters related to the heartbeat. Such parameters include: blood pressure waves, blood flow patterns, or the acoustic signal of a heartbeat.

Alternatively or additionally, the assisted motion of the cardiac assist device may be controlled according to a set sequence of assisted motions of the mitral valve plane simulating the natural cardiac cycle, thereby optimizing the cardiac assist function. The frequency, speed, and length of different pauses in the assisted movement can be set in the sequence to simulate natural or desired movement. Various parameters, such as the length of pauses in motion, can be varied over arbitrary time intervals, and these parameters can be set to vary according to a repetitive program. This sequence can be programmed into the computing/control unit 88 which controls the force generating unit. The force generating unit may then provide assisted motion according to a set sequence. Accordingly, energy from the energy source 84 may be controllably provided to the force generating unit in a set sequence to provide assisted motion.

Alternatively or additionally, the medical device may be incorporated into an artificial pacemaker system that controls or assists natural myocardial function. For example, the assisted movement of a cardiac assist device may be controlled by a processing unit of a pacemaker. A pacemaker including a processing unit may be implanted in a patient. A pacemaker triggers heart muscle activity in a manner known per se, for example artificially triggering a heartbeat via wires connected to the heart muscle tissue. The triggering of the assisted motion of the cardiac assist device may be controlled by the electrical triggering of the heartbeat (which has been synchronized with the cardiac cycle) by the artificial pacemaker system. Preferably, a time delay is provided for the triggering/activation of the assisted movement of the cardiac assist device during the cardiac cycle by triggering the electrical triggering of the myocardial activity. The amount of time delay can be optimized based on the delivery time of the electrical triggering of myocardial activity and the resulting pumping function of the heart brought about by the controlled contraction of the myocardium.

The remote energy source 84 may have a mechanical portion 90 that may transmit rotational or linear motion to the extension unit 54 . Rotary motion can be transferred directly from the electric motor, or the speed can be reduced using a gearbox. Rotational energy from the electric motor can be converted into linear motion, enabling pulling and pushing forces to be applied to the wire connection unit 54 extending all the way to the distal anchor location. Alternatively or in addition, mechanical portion 90 may include other actuators. For example, one or more electromagnets may be provided within the actuator capable of alternately providing pulling and pushing forces to the wire connection unit 54 extending all the way to the distal anchor location.

In addition, pulling and pushing from remote energy source 84 may also be accomplished by means of linear accelerators in mechanical section 90 . Alternatively or additionally, the mechanical portion 90 includes a Nitinol actuator, commercially available from MIGA Motor Company, Modern Motion, www.migamotors.com, that extends all the way to the distal anchor site by alternately using electricity to cool and heat The actuators that provide pulling and pushing forces for the extension unit 73 are, for example, metal wires or elongated carbon fiber flexible rods. Finally, in other embodiments, the remote energy source has no significant mechanical parts, instead a computer chip distributes power from the battery to one or more of the implanted cardiac assist devices based on signals related to the physiological cardiac cycle (eg, ECG signals). Electromagnets in each anchor unit or distributed to micromotors or linear actuators in the heart cavity or on the surface of the heart.

The remote energy source may have a rechargeable battery; the rechargeable battery is charged by a wire 94 passed through the skin when charging the battery connected to an external charging device (not shown). Charging can also be done wirelessly through the skin, for example by inductively transferring energy through an electromagnetic coil. Those skilled in the art can change and design this charging according to specific requirements and actual available technology.

18 and subsequent figures relate to a delivery system that is part of a treatment kit, medical procedures using the delivery system to deliver a cardiac assist device, and a medical method for therapeutically sustaining enhancement of left ventricular function in a patient.

In some embodiments, the remote energy source is located in the fatty tissue beneath the skin and adjacent to a blood vessel (preferably a large vein). This allows easy access to the heart. Alternatively, the energy source may be attached to the collarbone (not shown) to prevent misalignment of the energy source when delivering mechanical energy to the cardiac assist device inside the heart. A pocket or pouch 104 may be formed in the subcutaneous tissue near the actual access vessel (eg, the subclavian vein), see FIG. 18 .

The heart is shown in Figure 18 in relation to the great vessels and skin surface. A valved introduction catheter 100 (not shown) is passed through the skin into a large vein (in this case the subclavian vein 3 ), however any other sufficiently large vein may also be used for access. At the puncture site adjacent to the skin, a pouch 104 may be formed in the fatty tissue beneath the skin for containing the remote energy source 84 (not shown). An energy source may be attached to the collarbone (not shown) to prevent misalignment of the energy source when delivering mechanical energy to the cardiac assist device within the heart. The guide wire 102 is advanced to the right atrium 4 through the introduction catheter 100 . The coronary sinus is accessed via the right atrium using a guide catheter 106 (first shown in FIG. 21 ) and the guidewire is guided to the appropriate collateral of the coronary sinus venous system. In addition to the guide catheter, the kit also includes a delivery catheter loaded into different components. Figures 19 and 20 show examples of delivery systems, however only depicting the principles of delivery of the device. Figures 19a-c show how the push-pull system is delivered from the delivery system 98.

A delivery system for a cardiac assist device as shown in Figure 10a is shown in Figure 19a. The delivery system includes a delivery catheter 108 with a distal anchor 72 loaded on the tip. Advancement tube 110 , having an outer diameter smaller than the inner diameter of the delivery catheter, can be advanced axially inside advanced delivery catheter 108 to pull anchor 72 out of delivery catheter 108 at a desired location. Alternatively, the delivery catheter 108 may be retracted over the advancement catheter, thereby delivering the device despite any axial movement. A distal anchor unit 72 (shown here as a self-expanding stent) is attached to the extension unit 54 and leaves room for the extension unit 54 in the delivery catheter, thereby enabling the extension unit 54 to extend outside the patient, see Fig. 19b. Pusher tube 110 houses a lumen for guide wire 102 that also allows passage of anchor 72 . The distal anchor unit is released and expanded to securely anchor it into the surrounding vascular tissue. Thus, the distal anchor is in its proper position, with the extension unit 54 extending from the distal anchor.

Once the first anchor is in place, the second delivery catheter 116 shown in Figure 19c is advanced over the extension unit 54 until the guide unit 80 is aligned with the side branch where the distal anchor 72 is located. While the pusher catheter 110 is still secured in this position and the delivery catheter 116 is withdrawn, the side branch facing guide unit anchor 76 is properly released. Another aid for correct placement of the device is an X-ray marker 112 attached to the catheter for better visualization of the exact location of the catheter, eg by means of fluoroscopy.

Figure 20 depicts the positioning of a device that transmits rotational force to the coronary sinus. This delivery catheter 118 is similar to the delivery catheter shown in FIG. 19 , except that it may have an additional another lumen for accommodating additional guidewires 102 . Any other drawings of delivery systems housing other embodiment devices are not provided herein as variations will occur to those skilled in the art upon reading this disclosure.

21-25 illustrate a method 800 of inserting a cardiac assist system for permanent cardiac augmentation.

At step 800 , an introduction catheter 100 with a valve (not shown) is introduced through the skin into a large vein (eg, subclavian vein 3 ). Any other sufficiently large vein can also be used for access. Lead wire 102 is advanced through introduction catheter 100 to right atrium 4 . At step 810, the coronary sinus is accessed via the right atrium using the guide catheter 106 and the guidewire is guided to the appropriate collateral of the coronary sinus venous system. FIG. 21 a shows the use of guide catheter 106 to advance guidewire 102 into desired side branch 44 .

At step 820, the distal anchor 72 is released using the delivery catheter 108 in the side branch 44, as shown in FIG. 21b.

At step 830, as shown in Figure 22, the proximal anchor 76 is positioned at the opening of the side branch.

The positioning of the micromotor 70 by means of the delivery catheter 108 is shown in FIG. 23 .

Finally, the positioning of the rotating means is depicted in Figures 24a and 24b. How the guidewire 102 and guide catheter 106 are used to advance the guidewire into the anterior interventricular vein 42 is shown in FIG. 24a. In Fig. 24b, two anchors are depicted along with the loop 55. A separate lumen 114 can be utilized to accommodate another lead wire (in Figure 20c).

At step 840, a pouch 104 is formed in the subcutaneous fat tissue adjacent to the skin puncture site for receiving the remote energy source 84 (not shown). At step 850, an energy source may be attached to the collarbone (not shown) to prevent misalignment of the energy source when delivering mechanical energy to the cardiac assist device inside the heart.

At step 860 , once the two anchors are fixedly attached, the length of the extension unit 54 is adjusted and the extension unit 54 is attached to the remote energy source 84 , and at step 870 the system may be activated. The remote energy source has a unit that detects the natural motion of the heart, for example based on an electrocardiogram, blood pressure waves, sounds of heart activity, or blood flow. Thus, the remote energy source energizes the change in distance between the two anchors synchronously with the natural heart cycle, thereby enhancing the natural upward and downward motion of the mitral valve during the heart cycle.

A method is provided for continuously enhancing the pumping function of the left ventricle of a patient's heart, the method comprising controlled assisted mitral valve plane motion synchronized with the cardiac cycle of the heart.

A concurrently filed patent application titled "A DEVICE AND A METHOD FOR AUGMENTING HEART FUNCTION" claims U.S. Provisional Application Serial No. 61/317,631 filed March 25, 2010 and Swedish Application Serial No. SE1050283 filed March 25, 2010 -9 priority, the invention titles of these two applications are both "Device and a Method for Augmenting Heart Function", the applicants of these two applications are the same as this application, and the entire contents thereof are incorporated herein by reference. for all purposes. The copending application discloses devices and methods for moving the plane of the mitral valve within the heart to enhance the pumping effect of the left ventricle. Embodiments of the present disclosure may be combined with embodiments of the co-pending application. For example, an annuloplasty ring may be provided as an intra-atrial or intra-ventricular mitral valve anchor unit with a coronary sinus anchor unit or driver unit as described above. The prosthetic mitral valve can be combined with a coronary sinus anchor unit or a driving unit. It is good to mechanically provide a stable mitral valve plane and move more efficiently.

The invention has been described above with reference to specific embodiments. However, other embodiments than the ones described above are equally possible within the scope of the present invention. Different method steps or different sequences than those described above may be provided within the scope of the present invention. The different features and steps of the invention may be combined in other combinations than those described above. Several actuation principles (eg linear actuator and magnetic drive) can be combined with each other in certain embodiments. The scope of the invention is limited only by the appended patent claims.

Claims (10)

CLAIMS 1. A system for enhancing ventricular pumping function of a heart of a patient comprising: a motion assist unit for controllably providing assisting motion of a mitral valve synchronously with a cardiac cycle of said heart. 2. The system of claim 1, wherein the motion assisting unit includes a force generating unit for generating a force to achieve the assisted motion of the mitral valve. 3. The system of claim 1 or 2, further comprising: an implant capable of being placed in a cardiac vessel adjacent to the mitral valve of the left ventricle of the heart and connected to the mitral valve tissue of the left ventricle of the heart implant, wherein the motion assisting unit is adapted to apply a force to the implant when deployed in the cardiac vessel for obtaining the mitral valve motion from the motion of the implant. Assisting movement, and thereby obtaining movement of the mitral valve in the plane of the mitral valve towards and/or towards the apex of the heart. 4. The system of any one of claims 1-3, wherein the motion assisting unit is adapted to move the mitral valve in the mitral valve plane along the long axis of the left ventricle of the heart . 5. The system of any one of claims 1-4, wherein the motion assisting unit is adapted to reciprocate during systole towards the apex of the heart and during diastole away from the apex of the heart Movement moves the mitral valve of the heart. 6. The system according to any one of claims 1-5, wherein the motion assistance unit is adapted to generate the motion synchronized with the cardiac cycle of the heart by detecting the natural motion of the heart, for example by measuring ECG, blood pressure waves, blood flow, and/or acoustic signals of the heart and provides energy to displace the mitral valve in synchronization with the natural heart cycle, thereby enhancing the natural upward movement of the mitral valve during the heart cycle and downward movement. 7. The system of any one of claims 3-6, wherein the implant is sized to be placed in the coronary sinus of the heart adjacent the mitral annulus, and includes an expandable A distal anchoring unit, an expandable proximal anchoring unit, a connecting unit extending from the proximal anchoring unit to the distal anchoring unit, and the movement assisting unit includes a motor arranged to controllably vary the length of the connecting unit. The unit is actuated such that the movement of the mitral valve is assisted by said movement and the pumping action is enhanced. 8. The system of claim 7, wherein the connecting unit is adapted to vary the length along the short axis of the left ventricle and transversely to the long axis for assisting the lateral walls of the left ventricle with respect to the ventricular The natural inward and outward movement of the spacer. 9. The system of any one of claims 7-8, wherein the actuation unit is the force generating unit. 10. The system of any one of claims 7-9, wherein the linking unit is adapted to vary in length during a single cardiac cycle of the heart.